Evaluation Of Pessaries In Twin Pregnancies With A Short Cervix (25 mm) Between 20-28 WG (EPEGE)

Overview

Randomized, opened multicentric study evaluating the Effectiveness of Pessary in the patients with a Gemellary pregnancy and a collar runs between 20 and 28 weeks of amenorrhoea

Full Title of Study: “Evaluation Of Pessaries In Twin Pregnancies With A Short Cervix (25 mm) Between 20-28 WG”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2011

Detailed Description

Randomized, opened multicentric study evaluating the Effectiveness of Pessary in the patients with a Gemellary pregnancy and a collar runs between 20 and 28 weeks of amenorrhoea To show that the use of pessary makes it possible to lengthen the duration of the pregnancy of at least 10 days in patients with a twin pregnancy and a uterine collar length < = 25 mm measured by echography between 20 and 28 SA compared to the group controls.

Interventions

  • Device: Silicon ring positioned in the vagina, around the cervix
    • Silicon ring positioned in the vagina, around the cervix

Arms, Groups and Cohorts

  • Experimental: 1
    • Silicon ring positioned in the vagina, around the cervix
  • Experimental: 2
    • Silicon ring positioned in the vagina, around the cervix

Clinical Trial Outcome Measures

Primary Measures

  • Demonstrate the profit of 10 days in the pessary group compared to control.
    • Time Frame: at least 10 days
    • Demonstrate the profit of 10 days in the pessary group compared to control

Secondary Measures

  • To evaluate and compare the frequency of the childbirth < 34 SA
    • Time Frame: before 34 weeks
  • Deliveries (<34WG)
    • Time Frame: 34 weeks
    • Deliveries (<34WG)
  • Evaluate the rate of side effects of pessaries
    • Time Frame: during the pessaries
    • Evaluate the rate of side effects of pessaries
  • Neonatal outcome
    • Time Frame: before 28 weeks
    • Neonatal outcome

Participating in This Clinical Trial

Inclusion Criteria

  • Age > 18 years (legal majority in France) – Inclusion pessary positioning before 28 WG – Twin pregnancies, mono or dichorionic, diamniotic – Transvaginal cervical length ( 25mm between 20 et 28 WG – Intact membranes – No signs of infection (negative urine culture, CRP <10mg/l , blood white cell count <15000/ml) – Patient accepting follow-up – Covered by health insurance for France Exclusion Criteria:

  • Cerclage – No more cervix – Chorioamnionitis – Abnormal CTG – Placenta praevia – Abruptio – Bleeding – PROM – Singleton or multiple >2 – Monochorionic monoamniotic twin pregnancy – IUGR – Preeclampsia or other PIH – TTTS – Uncontrolled diabetes – Other maternal of fetal pathology responsible for preterm deliveries – Patient included in other therapeutic trials – Patient without legal freedom to consent – Homeless or no fixed address

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assistance Publique – Hôpitaux de Paris
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jacky NIZARD, CCA, Principal Investigator, Assistance Publique – Hôpitaux de Paris

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